Speakers

Kane Edgeworth, Biomap

Dr Afshin Hosseiny, Tabriz Consulting

Dr Andreas König, Fidelio Healthcare

Emil Schwan, Swedish Medical Products Agency

Objectives

During this course, well experienced speakers will share their expert knowledge about all relevant aspects regarding the current GMP and GDP requirements and current developments in storage, transportation and Cold Chain Management. You will learn how these requirements evolve and how they can be implemented efficiently.

Background

Globalisation, counterfeiting problems and the expectations regarding pharmaceutical storage, transport and cold chain management are forcing the pharmaceutical industry to challenge their current practices. Companies have to increase their effort and validation activities as one prerequisite for safe and secure storage and transportation of their medical products over boarders and through various climatic conditions.

Directives, Guides, Guidelines and initiatives from various regulatory bodies lead the way in this development and define expectations and requirements, where Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are closely linked.

Target Group

This education course is designed for all managers, supervisors and other staff members who are involved in pharmaceutical storage, transportation and cold chain and distribution activities and the control of those activities.

Roadmap to Good Distribution Practice

Each participant receives a Roadmap to Good Distribution Practice containing:

An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority

A checklist for the implementation of GDP principles

Programme

Regulatory Requirements and Guidance

What are the rules and regulations?

Who is responsible for maintaining product quality in the supply chain

Key challenges and criteria to consider

Cold Chain and ambient storage and transportation

The revised EU Guideline on Good Distribution Practice (GDP)

Who needs a Responsible Person (RP)?

The Roadmap to Success

Background and comments

Delineation of responsibilities

Introduction to the checklist

Roadmap to Good Distribution Practice
Each participant receives a Roadmap to Good Distribution Practice containing:

An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority

A checklist for the implementation of GDP principles

Best practices in Storage (how to implement requirements and stay efficient)